WATSON LABS INC FDA Approval ANDA 062844

ANDA 062844

WATSON LABS INC

FDA Drug Application

Application #062844

Application Sponsors

ANDA 062844WATSON LABS INC

Marketing Status

Discontinued001
Discontinued002
Discontinued003
Discontinued004
Discontinued005

Application Products

001INJECTABLE;INJECTIONEQ 500MG BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM
002INJECTABLE;INJECTIONEQ 1GM BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM
003INJECTABLE;INJECTIONEQ 1.5GM BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM
004INJECTABLE;INJECTIONEQ 2GM BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM
005INJECTABLE;INJECTIONEQ 4GM BASE/VIAL0NAFCILLIN SODIUMNAFCILLIN SODIUM

FDA Submissions

ORIG1AP1988-10-26
MANUF (CMC); Manufacturing (CMC)SUPPL2AP1988-11-10
MANUF (CMC); Manufacturing (CMC)SUPPL3AP1988-12-07
MANUF (CMC); Manufacturing (CMC)SUPPL4AP1990-11-07
MANUF (CMC); Manufacturing (CMC)SUPPL6AP1993-02-16
MANUF (CMC); Manufacturing (CMC)SUPPL9AP1993-11-09
MANUF (CMC); Manufacturing (CMC)SUPPL10AP1993-12-02
MANUF (CMC); Manufacturing (CMC)SUPPL11AP1994-01-13
MANUF (CMC); Manufacturing (CMC)SUPPL12AP1995-01-27
LABELING; LabelingSUPPL13AP1996-03-22
MANUF (CMC); Manufacturing (CMC)SUPPL14AP1995-12-15
MANUF (CMC); Manufacturing (CMC)SUPPL15AP1997-12-29
MANUF (CMC); Manufacturing (CMC)SUPPL18AP2000-12-08

Submissions Property Types

SUPPL1Null0
SUPPL2Null0
SUPPL3Null0
SUPPL4Null0
SUPPL6Null0
SUPPL9Null0
SUPPL10Null0
SUPPL11Null0
SUPPL12Null0
SUPPL14Null0
SUPPL15Null0
SUPPL18Null0

CDER Filings

WATSON LABS INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 62844
            [companyName] => WATSON LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 2GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"NAFCILLIN SODIUM","activeIngredients":"NAFCILLIN SODIUM","strength":"EQ 4GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"NAFCILLIN SODIUM","submission":"NAFCILLIN SODIUM","actionType":"EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAFCILLIN SODIUM","submission":"NAFCILLIN SODIUM","actionType":"EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAFCILLIN SODIUM","submission":"NAFCILLIN SODIUM","actionType":"EQ 1.5GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAFCILLIN SODIUM","submission":"NAFCILLIN SODIUM","actionType":"EQ 2GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"NAFCILLIN SODIUM","submission":"NAFCILLIN SODIUM","actionType":"EQ 4GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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